Caristo Diagnostics has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its CaRi-Plaque™ technology, an artificial intelligence-assisted image analysis application designed to aid in the diagnosis of coronary artery disease (CAD). This regulatory milestone advances the company's commercialization efforts in the United States as it prepares to deploy the technology to hospitals, health systems, and longevity clinics.
Coronary artery disease remains a leading cause of mortality worldwide, with inflammation-driven plaque buildup in arteries often progressing silently until a catastrophic cardiac event occurs. The CaRi-Plaque technology addresses this challenge by supporting non-invasive analysis of coronary anatomy and pathology from routine coronary computed tomography angiography (CCTA) scans.
Transforming Cardiac Diagnostics Through AI
The newly cleared technology determines the presence, extent, and severity of coronary plaques and luminal stenosis (narrowing of arteries). CaRi-Plaque builds upon Caristo's breakthrough core CaRi-Heart® technology, which a landmark Lancet 2024 study demonstrated can reveal hidden, high-risk markers of CAD progression—potentially predicting heart attacks up to a decade before they occur.
"For decades, heart disease has been treated reactively, waiting for symptoms to appear before taking action. But with AI, we can change that," said Frank Cheng, CEO of Caristo Diagnostics. "With FDA clearance for CaRi-Plaque, hospitals and clinics can now move beyond traditional diagnostics and into truly proactive, personalized heart attack prevention."
Cheng emphasized that by identifying both plaque buildup and hidden inflammation, Caristo is providing physicians with tools to identify high-risk patients earlier, tailor treatments more precisely, and ultimately save more lives.
Clinical Significance and Expert Perspectives
Stephen A. Bloom MD, MSCCT, FASNC, FACC, cardiologist and Director of Advance Imaging at Midwest Heart & Vascular Specialists in Kansas City, described the technology as revolutionary for coronary disease prevention and treatment.
"This advancement enables us to diagnose early stages of coronary disease, even before a coronary CT calcium score becomes positive, allowing for earlier intervention and treatment," Dr. Bloom stated. "We look forward to expanding our research and collaboration with Caristo to clinical adoption in the future."
The technology's potential impact on public health could be substantial. Dr. John Simon, Founder and CEO of SimonMed Imaging, the largest independent radiology practice in the United States, noted: "We now have the opportunity to prevent hundreds of thousands of deaths yearly from heart attack and stroke by using the knowledge gained from cardiac CT angiography combined with advanced AI technologies like the Caristo plaque program and the multiple treatment pathways now available."
Implementation and Workflow Integration
Integration of CaRi-Plaque into clinical workflows has been designed for simplicity. Healthcare professionals can send CT scan data to the cloud with a single mouse click. Caristo first de-identifies the data before processing the images through its CaRi-Plaque software for preliminary plaque analysis. Trained Caristo Operators then review the results, generate a CaRi-Plaque Report, and deliver it to the originating healthcare professional in either DICOM-conformant or PDF format.
The technology's precision and accuracy have been comprehensively validated against expert clinical consensus. The validation study determined the degree of consistency between plaque characteristics reported by CaRi-Plaque and qualified independent medical expert readers using a multi-center, international patient population.
Reimbursement and Future Developments
CaRi-Plaque is covered by the American Medical Association's new Category I CPT code, 75XX6, which takes effect in January 2026. Until then, CaRi-Plaque users are covered by the Category III CPT codes (0623T - 0626T), ensuring a pathway for reimbursement.
While CaRi-Plaque focuses on plaque analysis, Caristo's CaRi-Heart technology—which enables analysis of coronary inflammation—is currently available for research purposes only in the U.S. When cleared by the FDA, clinics using CaRi-Plaque will be able to seamlessly adopt CaRi-Heart, enabling the analysis of both plaque and coronary inflammation. This combination would provide an unprecedented, full-spectrum view of heart disease before symptoms arise.
About the Company
Caristo Diagnostics, a spinout from the University of Oxford, has positioned itself as a global leader in AI-powered heart disease detection. The company's mission centers on transforming cardiovascular care by identifying hidden heart attack risks before symptoms appear. Backed by leading hospitals and scientists, Caristo aims to save lives through early detection and personalized prevention strategies.
